Home / 510(k) Clearances / K062004

510(k) K062004

MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT by Quantum Orthopedics, Inc. — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2006
Date Received
July 17, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Quantum Orthopedics, Inc.

  • K061576 — MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM (July 3, 2006)
  • K052641 — MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT (April 12, 2006)
  • K060491 — QUANTUM ANTERIOR CERVICAL PLATE SYSTEM (March 13, 2006)
  • K050449 — QUANTUM VERTEBRAL BODY REPLACEMENT (July 7, 2005)
  • K040276 — QUANTUM CEMENT RESTRICTOR (April 30, 2004)

Other clearances for product code MQP

  • K253158 — VyBrate™ VBR System (January 7, 2026)
  • K241468 — Vertiwedge® Intraosseous System (November 7, 2024)
  • K232790 — KONG®-TL VBR System and KONG® C VBR System (April 4, 2024)
  • K233359 — DOMINION Expandable Corpectomy System (March 8, 2024)
  • K231134 — VerteLoc Spinal System (February 13, 2024)
  • K232173 — Ascend VBR System, Ascend NanoTec VBR System (October 6, 2023)
  • K211892 — ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (October 6, 2022)
  • K202637 — F3D Corpectomy System (December 23, 2020)
  • K200235 — KONG-TL VBR System, KONG-C VBR System (May 29, 2020)
  • K193506 — NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable (February 26, 2020)